CN100551396C - A kind of Chinese patent medicine for the treatment of fatty liver and preparation method thereof - Google Patents
A kind of Chinese patent medicine for the treatment of fatty liver and preparation method thereof Download PDFInfo
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Abstract
The invention provides a kind of Chinese patent medicine for the treatment of constitutional and secondary fatty liver, it mainly is to be made by following bulk drugs: 3～9 parts of 9～15 parts of Semen Cassiaes, 9～15 parts of Fructus Crataegis and Radix Panacis Quinquefoliis.The preparation method of product of the present invention is: with each crude drug of described weight portion proportioning with 30%～90% alcohol reflux after, in extracting solution, add on the pharmaceutics acceptable auxiliary and make dosage form pharmaceutically commonly used.The present invention is the clinical Chinese patent medicine that a kind of determined curative effect, toxic and side effects is little, workmanship is controlled, with low cost treatment fatty liver are provided, and it has remedied many deficiencies of treatment fatty liver medicine in the prior art.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine for the treatment of constitutional and secondary fatty liver and preparation method thereof.
Background technology
Fatty liver is the liver fat lesion that is caused by the multiple disease and the cause of disease, accumulates above the last per unit area of 5% or histology of liver weight in wet base for the hepatocyte inner lipid and sees 1/3 liver cell fatty degeneration, is called fatty liver.According to statistics, China fatty liver people is nearly 1.4 hundred million, in China big and medium-sized cities, the pathogenesis of fatty liver rate intelligent's mouth sum 8～10%, 30% of Shanghai sickness rate intelligent mouth sum, 26.1% of Beijing sickness rate intelligent mouth sum.The white collar class, the sickness rate of fatty liver reaches 25%; Adiposis patient and type ii diabetes people sickness rate are up to 50%.The fatty liver young and middle-aged people at 30～50 years old of mostly occurring, and continue the trend that becomes younger in addition, during the child is taken place, the ratio of severe fatty liver constantly increases, what have develops into hepatic fibrosis and liver cirrhosis.Along with the change of dietary structure and life style, the prevalence of fatty liver is in rising trend.Because the special clinical manifestation of the normal shortage of fatty liver often is considered to benign lesion, is just clarified a diagnosis when merging other disease or health check-up, has often incured loss through delay the state of an illness.The Fibrotic incidence rate of fatty liver is up to 25%, and has 1.5～8.0% patient to make progress to be to cause liver failure at last and death by liver cirrhosis.Fatty liver becomes one of hardened cercinoma prophase pathologic change of hepatic fibrosis regulating liver-QI, has become a public health problem, and the serious harm population health causes the great attention of the world of medicine.Up to now, the Western medicine that is used for the treatment of fatty liver clinically mainly contains following 6 classes: 1. choline and L carnitine; 2. the unsaturated lecithin of multivalence; 3. S-adenosylmethionine; 4. antioxidant; 5. ursodesoxycholic acid; 6. lipid lowerers.And the Chinese patent medicine that is specifically designed to the treatment fatty liver clinically is few, and the kind of having gone on the market only has the fatty liver treating notoginseng ball.
There is following problem in treatment fatty liver medicine at present: 1. uncertain therapeutic efficacy is cut, and it is unreliable to act on.A new generation's nicotinic acid class adverse effect is than obviously minimizing in the past, but its curative effect can not show a candle to clofibrate; Antioxidant might reduce the hepatic fibrosis that oxidative stress infringement lipid peroxidation causes, but remains to be proved its definite curative effect; After the drug withdrawal of the liver protecting and ALT lowering medicine, transaminase's bounce-back often appears.2. toxic and side effects is big.Untoward reaction as clofibrate mainly shows as epigastric discomfort, glutted burn feeling, appetite decline and laxativeness etc.; Choline, egg amino acid are taken the danger of bringing out hepatic encephalopathy for a long time; There is potential liver toxicity problem in metformin; Though the blood fat reducing medicine is used the more dispute that but exists in the treatment of fatty liver: think that many hypolipidemics may impel blood fat more to concentrate on liver and carry out metabolism, also impel lipid to store up and damage liver function, therefore in the patient of no obvious hyperlipemia, should blindly not take lipid lowerers for a long time.3. cost an arm and a leg.S-adenosine egg amino acid class is used for the treatment of alcoholic fatty liver as " Transmetil " and cholestasis type hepatopathy curative effect is better, but it costs an arm and a leg, and is difficult at no distant date clinically to be extensive use of; And for example the fatty liver treating notoginseng ball is the water-honeyed pill of being made by tens of flavor medicines such as Radix Notoginseng, Rhizoma Curcumae, and dosage form falls behind, and dose is big, and costs an arm and a leg.
Summary of the invention
Purpose of the present invention just is to provide the Chinese patent medicine of a kind of determined curative effect, toxic and side effects is little, cost of manufacture is cheap treatment fatty liver.
Another object of the present invention provides the preparation method of this Chinese patent medicine.
The present invention is in conjunction with the analysis to the fatty liver etiology and pathogenesis of traditional Chinese medicine theory and modern medicine, to the tradition application of prescription drug and the research of modern pharmacology, and the test of definite pharmacodynamic study is foundation, the Therapeutic Principle who rules together by the liver spleen of invigorating the spleen to clear away damp pathogen, blood circulation promoting and blood stasis dispelling, depressed liver-energy dispersing and QI regulating sets out, prescription reaches jointly and regulates the equilibrated purpose of liver fat in accordance with the law.
Semen Cassiae in the present invention's prescription is recorded in legendary god of farming's book on Chinese herbal medicine the earliest, main optic atrohic blindness, and order is puckery ... make light of one's life by commiting suicide.The Compendium of Material Medica record, Semen Cassiae tonifying liver gas.Semen Cassiae is sweet, bitter, salty, is slightly cold.Return liver, large intestine channel.Has wind and heat eliminating, liver heat removing tomorrow, the function of loosening bowel to relieve constipation.The clinical diseases such as conjunctival congestion and swelling pain, optic atrohic blindness, nyctalopia, constipation that are usually used in.Modern study is thought, the effect that Semen Cassiae has blood pressure lowering, blood fat reducing and cholesterol, protects the liver.Crataegolic acid in the present invention's prescription, sweet, tepor.Return spleen, stomach, Liver Channel.Has promoting digestion and invigorating the stomach, the effect of circulation of qi promoting dissipating blood stasis." daily book on Chinese herbal medicine " speech Fructus Crataegi can " relieving dyspepsia be long-pending, row stagnation of QI, the wide diaphragm of spleen invigorating, the blood mass at the hypochondrium that disappears piece." pathogenesis of fatty liver and liver, spleen be in close relations, and be in close relations with dietary factor, and Fructus Crataegi returns spleen, stomach, Liver Channel, has helping digestion only long-pending, the merit of circulation of qi promoting dissipating blood stasis both can have been changed meat stagnation, but promoting blood circulation to remove blood stasis again is the common drug of treatment fatty liver.And digestants can play the effect of protection gastric qi for the prolonged illness patient.Sweet, the little hardship of Radix Panacis Quinquefolii in the present invention's prescription, cold.GUIXIN, lung, kidney channel.Has boosting qi and nourishing yin, the effect of clearing away heat and promoting production of body fluid.China's " property of medicine is examined " states note " nourishing YIN is brought down a fever for Radix Panacis Quinquefolii-flavor class Radix Ginseng, only cold in nature, sweetness and bitterness ".Radix Panacis Quinquefolii is nourishing and body-strengthening, promoting the production of body fluid to quench thirst, the medication of enriching blood in the traditional Chinese medical science, can strengthen the spleen and stomach yang-energy, YIN and YANG balance regulating, strengthening vital QI to eliminate pathogenic factors, and the inherent adjusting potential of excitating organism is restored balance the disorder of organism metabolism.Radix Notoginseng, sweet, little hardship is returned liver, the heart, stomach warp, has the effect of blood circulation promoting and blood stasis dispelling, subduing swelling and relieving pain.In clinical, be used in the cardiovascular system diseases treatment more.
Modern pharmacological research shows that also Semen Cassiae has multiple pharmacological effect such as blood fat reducing, blood pressure lowering.Semen Cassiae mainly contains anthraquinone analog compound, wherein chrysophanic acid, Radix Et Rhizoma Rhei have protect the liver, the effect of function of gallbladder promoting.Anthraquinone glycoside can significantly reduce the content of plasma cholesterol and triglyceride, is the main component of its blood fat reducing.Semen Cassiae can reduce intestinal the absorption and the increase of cholesterol are drained, thereby reduce serum cholesterol level by its catharsis effect.The contained ketone of Fructus Crataegi, fat splitting enzyme etc. can reduce serum cholesterol, triacylglycerol, its lipolytic enzyme can promote steatolysis, the active ingredient total flavones that proposes in the Fructus Crataegi all has the speedup effect to platelet, erythrocyte electrophoresis, its electrophoresis time is significantly reduced, help improving hematodinamics, improve erythrocyte and platelet surface electric charge, increase repulsion between the cell, accelerate their flow velocitys in blood, promote axial flow, reduce mechanism such as limit stream and gathering adhesion, thus anticoagulant, and antithrombotic forms and reaches promoting blood circulation to remove blood stasis.Radix Panacis Quinquefolii has biologic activity widely, and mainly containing effective constituent is Radix Panacis Quinquefolii Saponin, can act on the panimmunity competent cell, promotes the secretion of some cytokine further to bring into play immunoregulation effect.It has significant protective effect to the immunocompromised that immunosuppressant causes.Radix Panacis Quinquefolii also plays important regulatory role to substance metabolism in addition, the damage when Radix Panacis Quinquefolii can alleviate the unusual and hyperlipidemia of lipoprotein-cholesterol level of hyperlipemia rat, blood lipid regulation.American ginseng total saponins influences protein, and lipid metabolism can blood sugar lowering.Radix Panacis Quinquefolii saponin can also reduce the weight of fatty tissue, the pancreatic lipase maximum inhibition is reached more than 90%, thereby suppress the absorption of small intestinal to fat.Arasaponin can stop intestinal absorption fat, cholesterol, in lipid metabolism, can reduce TL level and content of triglyceride.Hepatic ischemia-reperfusion injury is had the better protect effect, the circulation of the liver blood of improvement, blood flow increasing are arranged, protection blood-liver function of exchange alleviates hepatic necrosis. promote the effect of hepatic tissue reparation, regeneration and anti-hepatic fibrosis.
In sum, select the Semen Cassiae depressed liver-energy dispersing and QI regulating among the present invention for use, declare smooth mechanism of qi; Select Fructus Crataegi invigorating the spleen for eliminating dampness blood fat reducing, blood circulation promoting and blood stasis dispelling for use; Select for use Radix Panacis Quinquefolii to strengthen the spleen and stomach, regulate organism balance; The pseudo-ginseng blood-circulation-invigovating blood stasis dispelling promotes hepatocyte to repair.All medicines share, and are total to the merit that the long memorial liver spleen is invigorated blood circulation, and make the irritability catharsis, and spleen must be good for fortune, and blood stasis, phlegm-damp gradually remove, and reach the purpose of prevention and treatment fatty liver.
The object of the present invention is achieved like this: a kind of Chinese patent medicine for the treatment of fatty liver is characterized in that it mainly is to be made by following bulk drugs: 3～9 parts of 9～15 parts of Semen Cassiaes, 9～15 parts of Fructus Crataegis and Radix Panacis Quinquefoliis.
Be preferably: 9 parts of 15 parts of Semen Cassiaes, 15 parts of Fructus Crataegis and Radix Panacis Quinquefoliis.
Each amounts of components of medicine of the present invention can also be 3～9 parts of 9～15 parts of Semen Cassiaes, 9～15 parts of Fructus Crataegis, 3～9 parts of Radix Panacis Quinquefoliis and Radix Notoginseng.
Be preferably: 15 parts of Semen Cassiaes, 15 parts of Fructus Crataegis, 9 parts of 9 parts of Radix Panacis Quinquefoliis and Radix Notoginseng.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.As at first above-mentioned each crude drug being mixed the back with 30%～90% alcohol reflux by above-mentioned weight portion proportioning, extracting solution is reclaimed ethanol to there not being the alcohol flavor; In extracting solution, add on the pharmaceutics acceptable auxiliary then and make dosage form pharmaceutically commonly used.
Preferably, the preparation method of medicine of the present invention is as follows:
At first mix above-mentioned each crude drug back by above-mentioned weight portion proportioning with 30%～90% alcohol reflux; Extracting solution is reclaimed ethanol do not add the macroporous resin capital, with 30%～90% ethanol elution to there being alcohol flavor back; Collect ethanol elution at last, make dosage form pharmaceutically commonly used again after concentrating.
More preferably: above-mentioned each crude drug is used 30%～90% alcohol reflux respectively; Each extracting solution is reclaimed ethanol after having the alcohol flavor, do not add D101 macroporous resin column item respectively, ethanol elution with 30%～90%; Collecting each ethanol elution then concentrates; Make dosage form pharmaceutically commonly used again after mixing by above-mentioned weight portion proportioning at last.
Further the preparation method of preferred medicine of the present invention is: the Semen Cassiae in the above-mentioned raw materials medicine proportioning, Fructus Crataegi are mixed the back with 30%～90% alcohol reflux, extracting solution is reclaimed ethanol be not condensed into clear paste after having the alcohol flavor; Then the Radix Panacis Quinquefolii in the above-mentioned raw materials medicine proportioning is pulverized, added in the clear paste behind 100 mesh sieves excessively, make dosage form pharmaceutically commonly used again.
If also have Radix Notoginseng in the component of medicine of the present invention, its preparation method is: at first with after the Semen Cassiae in the above-mentioned raw materials medicine proportioning, Fructus Crataegi, the panax mixed with 30%～90% alcohol reflux, extracting solution is reclaimed ethanol is not condensed into clear paste after alcohol is distinguished the flavor of to having; Then the Radix Panacis Quinquefolii in the above-mentioned raw materials medicine proportioning is pulverized, added in the clear paste behind 100 mesh sieves excessively, make dosage form pharmaceutically commonly used again.
If more preferably: at first the Semen Cassiae in the above-mentioned raw materials medicine proportioning, Fructus Crataegi are mixed the back with 30%～90% alcohol reflux, extracting solution is reclaimed ethanol after having the alcohol flavor, be not condensed into clear paste; Then the Radix Panacis Quinquefolii in the above-mentioned raw materials medicine proportioning, Radix Notoginseng are pulverized, add in the clear paste behind 100 mesh sieves excessively, make dosage form pharmaceutically commonly used again.
The inventor causes " expectorant ", " wetting ", " stasis of blood " to be tied mutually in liver according to the cause of disease " dysfunction of the spleen in transportation, the liver failing to maintain the normal flow of QI, deficiency of the kidney " of fatty liver, Therapeutic Principle by invigorating the spleen to clear away damp pathogen, blood circulation promoting and blood stasis dispelling, depressed liver-energy dispersing and QI regulating carries out prescription, and has determined component of the present invention and proportioning according to the pharmacodynamics The selection result.In the component of the present invention: flavone that is contained in the Fructus Crataegi and triterpenoid compound have more sure effect for reducing fat to multiple hyperlipidemia model animal, its main effective ingredient is triterpenoid compound oleanolic acid and flavone compound hyperin, has the blood fat reducing hepatoprotective effect.Semen Cassiae can reduce serum total cholesterol, its main path that reduces serum cholesterol is not suppress cholesterol synthetic, but by following two metabolism that approach improves cholesterol, thereby reduce serum cholesterol concentration: (1) promotes that cholesterol changes into bile acid in the hepatocyte; (2) activity of low-density lipoprotein cholesterol (LDL) receptor in the raising hepatocyte promotes that LDL combines with ldl receptor, thereby promotes the elimination of LDL; Semen Cassiae can also reduce the content of triglyceride in the serum triglycerides regulating liver-QI, and the mechanism of blood fat reducing is the laxative action by Semen Cassiae anthraquinone glucosides, has reduced the absorption of intestinal to lipid.Radix Panacis Quinquefolii saponin suppresses the pancreatic lipase activity, thereby suppresses the absorption of small intestinal to fat, and Radix Panacis Quinquefolii can also be regulated the immunocompetence of body.Arasaponin can stop intestinal absorption fat, cholesterol, and the liver protecting blood circulation, blood flow increasing alleviate hepatic necrosis. promote the effect of hepatic tissue reparation, regeneration and anti-hepatic fibrosis.
The inventor by adopt high fat diet and ethanol to duplicate respectively to set up to human fatty liver because of, the very similar fatty liver model of pathological characters, to observe goods of the present invention to the dependency between effect, blood fat and the liver fat of fatty liver model blood fat reducing, its result is shown in following table 1, table 2, table 3.
Table 1 goods of the present invention are to the influence of high fat animal model
Annotate: model group Δ P＜0.05 of comparing with the normal control group, Δ Δ P＜0.01; Administration group * P＜0.05 of comparing with model group, * * P＜0.01.
In the table 1:
The normal control group: the base particle feedstuff of feeding gavages the normal saline with capacity such as administration groups every day.
Model group: 88% base particle feedstuff+10.0% Adeps Sus domestica+1.5% cholesterol of feeding+0.5% no. 3 bile salt prescription high lipid food gavages the normal saline with capacity such as administration group every day.
The administration group: 88% base particle feedstuff+10.0% Adeps Sus domestica+1.5% cholesterol of feeding+0.5% no. 3 bile salt prescription high lipid food gavages goods of the present invention every day.
Table 2 goods of the present invention are to the effect of alcoholic fatty liver
Annotate: model group Δ P＜0.05 of comparing with the normal control group, Δ Δ P＜0.01; Administration group * P＜0.05 of comparing with model group, * * P＜0.01.
In the table 2:
The normal control group: the base particle feedstuff of feeding gavages the normal saline with capacity such as administration groups every day.
Model group: the base particle feedstuff of feeding, irritate stomach and give ethanol every day, gavages the normal saline with capacity such as administration groups again.
The administration group: the base particle feedstuff of feeding, irritate stomach and give ethanol every day, gavages goods of the present invention again.
Table 3 goods of the present invention are to the influence (n=10) of high fat animal model and alcoholic liver animal model pathological change
Annotate: model group Δ P＜0.05 of comparing with the normal control group, Δ Δ P＜0.01; Administration group * P＜0.05 of comparing with model group, * * P＜0.01.
In the table 3: the normal control group in the high fat animal model, model group and administration group are identical with table 1, and the normal control group in the alcoholic liver model, model group and administration group are identical with table 2.
Annotate: hepatocyte fat become score into: the classification of fatty range degree: "-" lobules of liver structure is intact, does not have fat substantially and becomes; The change of "+" hepatocyte fat is no more than 25%; " ++ " hepatocyte fat becomes between 25%～50%; " +++" hepatocyte fat becomes between 50%～75%; " ++ ++ " hepatocyte fat becomes and surpasses 75%.During score, "-"～" ++ ++ " be considered as 0～4 fen successively.The score of inflammation mobility is with reference to the score standard of Knodell.The inflammation degree is scored respectively in portal area and the lobule, and specifically score standard is: NIP, necrosis in portal area or the lobule, counted 0 fen; Inflammation, necrosis are arranged in portal area less than 1/3 or the lobule, counted 1 fen; Inflammation, necrosis are arranged in 1/3～2/3 portal area or the lobule, counted 3 fens; In portal area above 2/3 or the lobule inflammation, necrosis are arranged, counted 4 fens, a total score is calculated in every section, and total is divided into the score and the inflammation mobility score sum of steatosis.
The inventor by adopt high fat diet and ethanol to duplicate respectively to set up to human fatty liver because of, the very similar fatty liver model of pathological characters, observe the influence of goods of the present invention to the fatty liver model biochemical indicator.The result shows: goods of the present invention raise to high-fat fatty liver rat model serum NSC 334200 aminotransferase (ALT), Aspartic Acid aminotransferase (AST) and serum lipids TC, TG obvious reduction effect; Free serum fatty acid (FFA), malonaldehyde (MDA), whole blood shear rate (low cutting) and erythrocyte aggregation index rising there is obvious reduction effect; The active reduction of serum superoxide dismutases (SOD) there is obvious rising effect.Alcoholic fatty liver rat model hepatic tissue TC, TG, FFA rising there is obvious reduction effect; And hepatic lipase (HL), lipoprotein lipase (LPL), the active reduction of SOD are had obvious rising effect.These results show that goods of the present invention are good to the prevention and the therapeutic effect of the fatty liver that causes because of high fat, ethanol and chemical damage, have obvious, definite curative effect.
In addition, the inventor confirms that by pharmacological evaluation goods of the present invention can obviously reduce the content that DL-ethionine and tetracycline cause mice fatty liver liver fat, the results are shown in Table 4, table 5.Credit is analysed by statistics, no matter is at ethionine fatty liver model, and still at tetracycline fatty liver model, the administration group all raises to TG content in the Mouse Liver obvious reduction effect.
Table 4 goods of the present invention are to the influence of ethionine model mice liver TG content (x ± s)
In the table 4:
Normal control group: gavage normal saline every day with capacity such as administration groups.
Model group: gavage the normal saline with capacity such as administration groups every day, and began to give the DL-ethionine in the 4th day.
Administration group: gavage goods of the present invention every day, and began to give the DL-ethionine in the 4th day.
Table 5 goods of the present invention are to the influence of tetracycline fatty liver model mice liver TG content (x ± s)
Annotate: model group Δ Δ P＜0.01 of comparing with the normal control group; Administration group * P＜0.05 of comparing with model group, * * P＜0.01.
In the table 5:
Normal control group: gavage normal saline every day with capacity such as administration groups.
Model group: gavage the normal saline with capacity such as administration group every day, and in the 8th day beginning lumbar injection tetracycline.
The administration group: gavage goods of the present invention every day, and in the 8th day beginning lumbar injection tetracycline.
Comprehensive above-mentioned research and experimental result, the inventor thinks that goods of the present invention have the effect that the prevention experimental fatty liver takes place, its mechanism of action with adjusting lipid metabolism, improve liver function, antioxidation is relevant; The molecular mechanism of action of prevention fatty liver may be relevant with the expression that increases PPAR γ and LDLR.Above-mentioned research simultaneously and experimental result show that also goods of the present invention have sure curative effect to the acute fatty liver model.
The acute toxicity test of goods of the present invention: the maximal dose proportioning commonly used by goods of the present invention has been carried out the chmice acute toxicity test, and goods ALD of the present invention as a result is 332g crude drug/kg.Toxic reaction is that animal tiredly crouches after the administration, spontaneous activity reduces, breathe slack-off intensification, alarm hair, close one's eyes etc., becomes celestial and finds animal small intestinal hydrops, and all the other internal organs show no obvious abnormalities.
The histopathology morphology of goods of the present invention shows (seeing Table 3) by the grading evaluation result of steatosis degree and inflammation mobility, and administration group steatosis and inflammatory reaction degree all have significantly than model group and alleviate, and other internal organs are not seen untoward reaction.Accompanying drawing 1～Fig. 6 is seen in the section of liver organization pathology.
Perusal rats in normal control group liver color is scarlet, quality softness, high resilience; The model control group liver is lark, and volume increases, and the edge is blunt and thick, and tangent plane is greasy feeling slightly.Om observation normal control group (seeing Fig. 1, Fig. 4) rat hepatocytes is that the center is radial arrangement towards periphery with the central vein, liver cell nuclear is justified greatly, is positioned at cell central authorities, does not see that cloudy swelling, fat become or necrosis, the liver organization structure is normal, does not see obvious pathological change; During model control group (seeing Fig. 2, Fig. 5) is visible or severe hepatocyte fat become, it is disorderly that the lobules of liver structure shows slightly, and is full of in the endochylema that fat drips cavity or foam sample fat drips cavity, and visible chronic inflammatory cell infiltration and proliferation of fibrous tissue.The also visible hepatocyte fat change of administration group (seeing Fig. 3, Fig. 6) and chronic inflammatory cell infiltration and proliferation of fibrous tissue, comparatively obvious but administration group steatosis and inflammatory reaction degree all alleviate than model group.
Rat long term toxicity test by 6 months, with goods of the present invention respectively by 80g/kg, 40g/kg and three dosage groups of 20g/kg (be equivalent to respectively clinical dosage 90,60,30 times) and normal control group, continuous 180 days ig (filling stomach) rats were respectively cutd open 12,16,12 rats extremely in 90 days, 180 days and 210 days after the administration.Observed general situation such as body weight, appetite and feces respectively; Detect physiochemical indice and biochemical indicator; It the results are shown in Table 6, table 7.
The variation of table 6 goods filling of the present invention stomach rat long term toxicity test routine blood test (x ± s)
Annotate: * be with the normal control group this, * * is P＜0.01, * is P＜0.05.
The variation of table 7 goods filling of the present invention stomach rat long term toxicity test blood parameters (x ± s)
At experimental session, goods of the present invention do not have obvious influence to the general situation of rat, and heavy dose of group male rat body weight and appetite reduce, and with the normal control group notable difference are arranged, and can recover after the drug withdrawal.As can be seen from Table 6, during administration 90 days, the HGB of middle dosage group was low than matched group, can recover after the drug withdrawal; The W-SCR of small dose group is low than matched group, and W-LCR can recover after the drug withdrawal than the matched group height.The HGB of 180 days small dose group, HCT, PLT can recover after the drug withdrawal than the matched group height.Each index was compared with matched group and is not seen notable difference after administration stopped.As seen from Table 7, the CK of d90 low dose, K during administration
+, Cl
-Raise, GLU reduces, in, heavy dose of K
+Raise; The CK of d180 low dose, K
+, Cl
-, the TC of middle dosage, K
+, Na
+, Cl
-, heavy dose of TG all raises, in, heavy dose of TBIL reduces, and with matched group notable difference arranged relatively.After the drug withdrawal, the K of little, middle dosage
+, the CK of each dosage group can not recover still than the matched group height, and other abnormal indexes can recover.Above results suggest, goods long term administration toxicity of the present invention is less, and the rat safe dose is 40g/kg, can be applied to clinical fully safely.
After goods of the present invention have adopted on preparation method Semen Cassiae, Fructus Crataegi, Radix Panacis Quinquefolii have been mixed by the proportioning among the present invention, use 75% alcohol reflux, reclaim ethanol, be added on D101 macroporous resin capital to there not being the alcohol flavor, carry out eluting with 75% ethanol, collect ethanol elution, reclaim ethanol, concentrate, dry, add appropriate amount of auxiliary materials, granulate, incapsulate.The medical material of respectively distinguishing the flavor of more than the present invention can also adopt extracts separately, and then mixes by the proportioning among the present invention, and its advantage is to control the quality of each extract better, but technological process is longer, and operation is trouble relatively.The present invention also can beat Radix Panacis Quinquefolii in the proportioning or Radix Notoginseng in the powder adding clear paste, can reduce the consumption that extracts adjuvant in used solvent consumption and the preparation process like this, thereby reduce cost.The advantage of preferable preparation technique of the present invention shows that mainly when guaranteeing curative effect, technological process is shortened, and is easy and simple to handle, reduced taking dose widely, makes things convenient for the patient to take.
Goods of the present invention have adopted the macroporous adsorbent resin technology to carry out separation and purification on preparation method, make the goods of the present invention that obtain when guaranteeing curative effect, greatly reduce taking dose, provide more choices for clinical.
Goods of the present invention can also be the capsule that adopts ethanol extraction and the isolating technology of macroporous adsorbent resin to make, and technical process is simple, easy and simple to handle, equipment requirements is not high, and the medicine source is abundant, and cost of manufacture is lower, has the feasibility of big production.This product taking dose is little, preserves, transports, carries all more convenient, and capsule can cover the bitterness of medicine itself, and appearance looks elegant helps strengthening the compliance that patient takes medicine.
In a word, the present invention is the clinical Chinese patent medicine that a kind of determined curative effect, toxic and side effects treatment fatty liver little, quality controllable, with low cost is provided, and it has remedied many deficiencies of treatment fatty liver medicine in the prior art.
Goods of the present invention are used for the treatment of fatty liver, and its diseased region is liver, and the course of disease is long, need the long period to take medicine, and for convenient drug administration, strengthen the compliance that patient takes medicine, and reach curative effect preferably simultaneously, so this product adopts the mode of oral administration.Taking dose of the present invention calculates according to test of pesticide effectiveness result, the rat effective dose is 15.0g/kg, people's dose,equivalent is 2.32g/kg/ day, then referrer's clinical initial dose is 1/3-1/5 people's dose,equivalent, it is 0.464-0.773g/kg/ day, in adult's average weight 60kg, then day initial crude drug amount of clothes is 27.840g～46.380g.By the preparation method among the present invention, on average receiving the cream rate is 4.9%, and then a day clothes extractum amount is 1.364～2.273g, if take 3 times every day, then each dose is 0.455～0.758g, 2～3 capsules of can packing into, every dress 0.25g is 2～3/time so this product is recommended initial dose.
Description of drawings
Fig. 1 is the om observation figure of the rat liver histopathology section of normal control group in the high fat animal model;
Fig. 2 is the om observation figure of the rat liver histopathology section of model control group in the high fat animal model;
Fig. 3 is the om observation figure of the rat liver histopathology section of administration group in the high fat animal model;
Fig. 4 is the om observation figure of the rat liver histopathology section of normal control group in the alcoholic liver model;
Fig. 5 is the om observation figure of the rat liver histopathology section of model control group in the alcoholic liver model;
Fig. 6 is the om observation figure of the rat liver histopathology section of administration group in the alcoholic liver model.
The specific embodiment
Further specify the present invention below by embodiment, but the present invention not only is confined to these embodiment.
Embodiment 1: the preparation of medicine capsule of the present invention
Depend on pine torch 15kg, Fructus Crataegi 12kg, Radix Panacis Quinquefolii 9kg, pulverize mixing, use 30% alcohol reflux, reclaim ethanol, concentrate, add proper auxiliary materials and granulate, encapsulated.
Embodiment 2: the preparation of medicine capsule of the present invention
Depend on pine torch 12kg, Fructus Crataegi 9kg, Radix Panacis Quinquefolii 6kg, pulverize mixing, use 50% alcohol reflux, reclaim ethanol, concentrate, add proper auxiliary materials and granulate, encapsulated.
Embodiment 3: the preparation of medicine capsule of the present invention
Depend on pine torch 9kg, Fructus Crataegi 15kg, Radix Panacis Quinquefolii 3kg, pulverize mixing, use 90% alcohol reflux, reclaim ethanol, concentrate, add proper auxiliary materials and granulate, encapsulated.
Embodiment 4: the preparation of medicine capsule of the present invention
Depend on pine torch 9kg, Fructus Crataegi 15kg, Radix Panacis Quinquefolii 9kg, Radix Notoginseng 9kg pulverizes mixing, uses 90% alcohol reflux, reclaims ethanol, concentrates, and adds proper auxiliary materials and granulates, and is encapsulated.
Embodiment 5: the preparation of medicine capsule of the present invention
Depend on pine torch 12kg, Fructus Crataegi 9kg, Radix Panacis Quinquefolii 6kg, pulverize mixing, use 30% alcohol reflux, reclaim ethanol, be condensed into clear paste, Radix Notoginseng 6kg pulverized 100 mesh sieves, added in the clear paste, added proper auxiliary materials again and granulated, and was encapsulated.
Embodiment 6: the preparation of medicine capsule of the present invention
Depend on pine torch 15kg, Fructus Crataegi 10kg, pulverize mixing, use 60% alcohol reflux, reclaim ethanol, be condensed into clear paste, Radix Panacis Quinquefolii 3kg, Radix Notoginseng 3kg pulverized 100 mesh sieves, added in the clear paste, added proper auxiliary materials again and granulated, and be encapsulated.
Embodiment 7: the preparation of medicine capsule of the present invention
Depend on pine torch 12kg, Fructus Crataegi 9kg, Radix Panacis Quinquefolii 3kg add 75% alcohol reflux respectively, reclaim ethanol, concentrate, and are added on D101 macroporous resin capital respectively, use 30% ethanol elution, collect each eluent, reclaim ethanol, concentrate, and drying is granulated, and is encapsulated.
Embodiment 8: the preparation of medicine capsule of the present invention
Depend on pine torch 9kg, Fructus Crataegi 15kg, Radix Panacis Quinquefolii 9kg pulverize mixing, add 30% alcohol reflux, reclaim ethanol, concentrate, and are added on AB-8 macroporous resin capital, use 50% ethanol elution, collect eluent, reclaim ethanol, concentrate, and drying is granulated, and is encapsulated.
Embodiment 9: the preparation of medicine capsule of the present invention
Depend on pine torch 15kg, Fructus Crataegi 12kg, Radix Panacis Quinquefolii 6kg pulverize mixing, add 90% alcohol reflux, reclaim ethanol, concentrate, and are added on SP70 macroporous resin capital, use 90% ethanol elution, collect eluent, reclaim ethanol, concentrate, and drying is granulated, and is encapsulated.
Embodiment 10: the preparation of medicine capsule of the present invention
Depend on pine torch 11kg, Fructus Crataegi 10kg pulverizes mixing, add 30% alcohol reflux, reclaim ethanol, concentrate, be added on X-5 macroporous resin capital, use 50% ethanol elution, collect eluent, reclaim ethanol, be condensed into clear paste, Radix Panacis Quinquefolii 3kg pulverized 100 mesh sieves, added in the clear paste, add appropriate amount of auxiliary materials again and granulate, encapsulated.
Embodiment 11: the preparation of medicine capsule of the present invention
Depend on pine torch 13kg, Fructus Crataegi 10kg pulverizes mixing, add 60% alcohol reflux, reclaim ethanol, concentrate, be added on HP20 macroporous resin capital, use 70% ethanol elution, collect eluent, reclaim ethanol, be condensed into clear paste, Radix Panacis Quinquefolii 3kg, Radix Notoginseng 4kg pulverized 100 mesh sieves, added in the clear paste, add appropriate amount of auxiliary materials again and granulate, encapsulated.
Embodiment 12: the preparation of medicinal tablet of the present invention
Set of dispense ratio and preparation process are with embodiment 11, and different is to add appropriate amount of auxiliary materials, tabletting.
Embodiment 13: the preparation of medicinal granule of the present invention
Set of dispense ratio and preparation process are with embodiment 10, and different is to add appropriate amount of auxiliary materials, makes granule.
Embodiment 14: the preparation of bolus of drug of the present invention
Set of dispense than and preparation process with embodiment 9, the extract powder adding appropriate amount of auxiliary materials that different is behind the concentrate drying is round as a ball in the high-efficiency coating pot, makes pill.
Embodiment 15: the preparation of medicine oral liquid of the present invention
Set of dispense ratio and preparation process are with embodiment 6, and different is to add appropriate amount of auxiliary materials, makes oral liquid.
Embodiment 16: the preparation of medicament slow release preparation of the present invention
Set of dispense than and preparation process with embodiment 4, the extract powder adding appropriate amount of auxiliary materials that different is behind the concentrate drying is made slow releasing preparation.
Claims (10)
1, a kind of Chinese patent medicine for the treatment of fatty liver is characterized in that it is to be made by following bulk drugs: 3～9 parts of 9～15 parts of Semen Cassiaes, 9～15 parts of Fructus Crataegis and Radix Panacis Quinquefoliis.
2, the Chinese patent medicine of treatment fatty liver as claimed in claim 1, wherein the consumption of each crude drug is: 9 parts of 15 parts of Semen Cassiaes, 15 parts of Fructus Crataegis and Radix Panacis Quinquefoliis.
3, a kind of Chinese patent medicine for the treatment of fatty liver is characterized in that it is to be made by following bulk drugs: 3～9 parts of 9～15 parts of Semen Cassiaes, 9～15 parts of Fructus Crataegis, 3～9 parts of Radix Panacis Quinquefoliis and Radix Notoginseng.
4, the Chinese patent medicine of treatment fatty liver as claimed in claim 3, wherein the consumption of each component is: 9 parts of 15 parts of Semen Cassiaes, 15 parts of Fructus Crataegis, 9 parts of Radix Panacis Quinquefoliis and Radix Notoginseng.
5, as the preparation method of the Chinese patent medicine of the described treatment fatty liver of arbitrary claim in the claim 1～4, it comprises the following steps: at first described each crude drug to be mixed the back with 30%～90% alcohol reflux by described weight portion proportioning, and extracting solution is reclaimed ethanol to there not being the alcohol flavor; In extracting solution, add on the pharmaceutics acceptable auxiliary then and make dosage form pharmaceutically commonly used.
6, the preparation method of the Chinese patent medicine of treatment fatty liver as claimed in claim 5 wherein saidly reclaims ethanol with extracting solution and does not add the macroporous resin capital to there being alcohol flavor back, with 30%～90% ethanol elution; Collect ethanol elution at last, make dosage form pharmaceutically commonly used after concentrating.
7, as the preparation method of the Chinese patent medicine of the described treatment fatty liver of arbitrary claim in the claim 1～4, it comprises the following steps: at first described each crude drug to be used 30%～90% alcohol reflux respectively, reclaim ethanol, mix by described weight ratio, acceptable auxiliary is made dosage form pharmaceutically commonly used on the adding pharmaceutics.
8, as the preparation method of the Chinese patent medicine of the described treatment fatty liver of arbitrary claim in the claim 1～4, it comprises the following steps: at first described each crude drug to be used 30%～90% alcohol reflux respectively; Then each extracting solution is reclaimed ethanol and after having the alcohol flavor, do not add the macroporous resin column item respectively, ethanol elution with 30%～90%; Collecting each ethanol elution concentrates; Mix by described weight portion proportioning at last, make dosage form pharmaceutically commonly used.
9, as the preparation method of the Chinese patent medicine of the described treatment fatty liver of claim 1～4, it comprises the following steps: at first the described crude drug except that Radix Panacis Quinquefolii to be mixed the back with 30%～90% alcohol reflux by proportioning, extracting solution is reclaimed ethanol be not condensed into clear paste after having the alcohol flavor; Then the Radix Panacis Quinquefolii in the described crude drug proportioning is pulverized, added in the clear paste behind 100 mesh sieves excessively, make dosage form pharmaceutically commonly used again.
10, as the preparation method of the Chinese patent medicine of claim 3 or 4 described treatment fatty livers, it comprises the following steps: at first the Semen Cassiae in the described crude drug proportioning, Fructus Crataegi to be mixed the back with 30%～90% alcohol reflux, extracting solution is reclaimed ethanol be not condensed into clear paste after having the alcohol flavor; Then the Radix Panacis Quinquefolii in the described crude drug proportioning, Radix Notoginseng are pulverized, add in the clear paste behind 100 mesh sieves excessively, make dosage form pharmaceutically commonly used again.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP6145552B1 (en) * | 2016-11-18 | 2017-06-14 | 正則 那須 | Fatty liver treatment composition |
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| CN106309719A (en) * | 2015-06-24 | 2017-01-11 | 北大方正集团有限公司 | Medicinal composition for treating fatty livers |
| CN110101736A (en) * | 2019-04-11 | 2019-08-09 | 华中科技大学 | It is a kind of for the cassia seed extract of hypoglycemic and its preparation and quality detecting method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP6145552B1 (en) * | 2016-11-18 | 2017-06-14 | 正則 那須 | Fatty liver treatment composition |
| US10849950B2 (en) | 2016-11-18 | 2020-12-01 | Masanori NASU | Composition for treating fatty liver |
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| CN101112432A (en) | 2008-01-30 |
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